Home NDC 36800-504-03 Severe Cold PE
Product NDC 36800-504
Requested package NDC 36800-504-03
11-digit product format 368000504
Labeler code 36800
Product ID 36800-504_ee9ee462-3f1c-6c94-e053-2995a90a9de4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler TopCare
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-07-01
Marketing end 2023-03-31
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEVERE COLD PE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-504-03 36800050403 2 BLISTER PACK in 1 CARTON (36800-504-03) > 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2013-07-01 2023-03-31 No No Current